The instant invention is a topically applied therapeutic composition containing an alkali metal hypohalite (AMH). More particularly, the instant invention is a topically applied lotion that delivers AMH into the subcutaneous tissue and, thereby, stimulates the immune system to treat, and in some cases cure, a variety of ailments including: viral infections (e.g., colds, herpes, HIV infection, and shingles); microbial infections, Lyme disease, dermatitis; allergies; hemorrhoids; arthritis; and gout.
The most common AMH is sodium hypochlorite (NaOCl). Sodium hypochlorite is the active agent in household bleach and has been used as a bactericide since the beginning of the 19th century.
A number of compositions containing sodium hypochlorite have been patented. Representative patents include U.S. Pat. Nos. 4,737,307; 4,927,641; 5,273,678; 5,472,714; and 5,427,801.
U.S. Pat. No. 4,737,307 is directed to a skin cleanser capable of removing smegma and surface bacteria fungus and viruses from the surface of the skin. The cleanser is an aqueous solution of cetylpyridinium chloride, chlorine dioxide, sodium hypochlorite, polyoxyethylene (20) sorbitan monostearate and sodium benzoate.
U.S. Pat. No. 4,927,641 is directed to a veterinary liniment and method of employing the same. The liniment comprises dimethlysulfoxide and sodium hypochlorite. The liniment is preferably a thin liquid but may be in the form of a lotion, gel, or cream.
U.S. Pat. No. 5,273,678 is directed to a stable aqueous solution containing sodium hypochlorite, a pH regulator, and water. The solution is used as an antiseptic.
U.S. Pat. Nos. 5,472,715 and 5,427,801 are directed to an antifungal agent for the treatment of skin diseases, such as athlete""s foot, ringworm and tinea, caused by dermatophytes, eczema, tinea or various fungi. The antifungal agent comprises a detergent solution of sodium hypochlorite, sodium sulfite, sodium nitrate, sodium chlorate, potassium chlorate, hydrogen peroxide, oxone water, sodium nitrite, potassium nitrite, nonionic surface active agent, and water.
With the exception of U.S. Pat. No. 4,927,641, these references are directed to compositions where any active ingredient appears to remain in the epidermal layer of the skin, i.e., the uppermost layer of the skin cells. None of these references recognize AMH""s ability to stimulate the immune system and alleviate and/or cure the aches, pains, inflammation, itching, and other symptoms of many common maladies including viral infections (e.g., colds, herpes, HIV infection, and shingles), microbial infections, dermatitis, Lyme disease, allergies, hemorrhoids, arthritis and gout. Finally, the preferred topical system in all of these references is a solutionxe2x80x94not a lotion.
There are a number of antimicrobial (e.g., antiviral, antibacterial, antifungal, antiparasitic) treatments on the market today for treating infections in subcutaneous tissue. In addition, there is a large body of art dedicated to treating internal ailments such as hemorrhoids, arthritis and allergies. However, most of the treatments disclosed in the art deliver the active ingredient orally (i.e., in a pill, capsule or liquid form) or intravenously (i.e., by injection). These delivery methods, while effective, are problematic. Intravenous delivery can be difficult and is relatively costly. Oral delivery is often hampered by the foul taste of the active ingredient employed.
In addition, many of these treatments cause side effects. Common side effects include fatigue, raised blood pressure, skin irritation, and a weakened immune system.
The present invention is directed to a topically applied therapeutic composition. The composition comprises: (i) an alkali metal hypohalite (AMH); and (ii) a commercially available lotion. The final composition (hereinafter referred to as the xe2x80x9ctherapeutic lotionxe2x80x9d) is applied over the region of the body where symptoms, such as aches, sores, and inflamation, first arise.
The AMH is the active ingredient and is preferably sodium hypochlorite. The instant invention delivers AMH to the dermal, epidermal and, most importantly, to the subcutaneous tissue. Once in the body, the AMH stimulates the immune system to treat, and in some cases cure, a variety of ailments including viral and bacterial infections such as the common cold, herpes, Lyme disease, HIV infection and shingles; dermatitis; allergies; hemorrhoids; arthritis; gout; and elevated prostrate specific antigen.
The lotion component of the composition serves as both a carrier and anti-drying agent for the AMH. The lotion prevents the AMH from drying before it has enough time to penetrate through the skin pores and lymph nodes and down into the subcutaneous layers of tissue.
The invention does not cause common side effects, such as fatigue, raised blood pressure, or skin irritation. Nor does the invention adversely affect the user""s immune system.
The composition comprises, at the very least, an AMH and a conventional skin lotion. Other optional ingredients include common skin care aids and treatments such as Aloe Vera extract; petroleum jelly, mineral oil, vegetable oil, anti-inflammatory agents, and odor masking or emitting agents. Odor masking or emitting agents are especially desirable to mask the smell of the AMH.
Preferably, the AMH is the principal active ingredient in the composition. More preferably, the AMH is the only active agent.
The preferred AMH is sodium hypochlorite. Another suitable AMH is potassium hypochlorite.
The lotion component of the therapeutic lotion serves as the carrier, or vehicle, for the AMH. Lotions, in contrast to solutions, do not need to be rubbed into the skin in order to stay in place, even though it is preferable to do so. Preferably, the lotion is in the form of a semi-viscous or viscous ointment, such as a cream or gel. Higher viscosity increases residence time, i.e., the time in which the active ingredient is in contact with the proper location of the body. Preferably, the lotion is the principal carrier and, more preferably, the only carrier.
In addition, the lotion component of the therapeutic lotion serves as an antidrying agent. It allows the AMH component to remain sufficiently liquid, for a sufficient period of time, to penetrate the epidermal and dermal layers of the skin through skin""s pores and lymph nodes. If lotion, or an equivalent antidrying agent, is not employed, the AMH drys up almost immediately after application (within seconds) and is not effective. In contrast, when an AMH, such as sodium hypochlorite, is combined and mixed with skin lotion, it can remain active in a penetrable liquid state for more than 30 minutes. Preferably the lotion is the principal anti-drying agent and, more preferably, the only anti-drying agent.
The identity of the lotion component is not especially critical. The majority of lotions currently on the market are acceptable. The only real requirement is that the lotion cannot contain highly basic materials such as ammonia since such compounds may react with the AMH component.
Preferred lotion components contain the healing plant Aloe Vera, or an extract from the same. One especially preferred skin lotion is marketed under the brand name ST. IVE""S THERAPY LOTION(trademark) which contains water, mineral oil, glyceryl stearate SE, steric acid, cytyl alcohol, Aloe, petrolatum, magnesium aluminum silicate, iocopheryl acetate (Vitamin E), glycerin dimethicone, rosemary extract, matreciarin extract (chamoline), sage extract, white nettle extract, retinyl palmitato (Vitamin A), cholecalicferol (Vitamin D), vegetable oil, sodium lauryl sulfate, phenoxyethanol, methylparalein, propyparaben, titrosodium, EDTA, fragrance yellow 5, blue 1.
The amount of AMH in the therapeutic lotion varies with the specific ailment being treated. For most ailments, anywhere from 10 milliliters (circa 0.33 fluid ounces) to 120 milliliters (circa 4.0 fluid ounces) of a 7.25% by volume aqueous solution of AMH (e.g., sodium hypochlorite) is added to 532 milliliters (circa 18 fluid ounces) of lotion component. More preferably, a 7.25% by volume aqueous solution of AMH is added in an amount ranging from 30 milliliters (circa 1 fluid ounce) to 90 milliliters (circa 3 fluid ounces) to 532 milliliters of lotion component. Obviously, proportionally less AMH solution is needed when the AMH in the solution is in a concentration higher than 7.25% by volume and proportionally more solution is needed when the AMH in the solution is in a concentration less than 7.25% by volume. These figures roughly correspond to a concentration of pure AMH that makes up about 0.13% to about 1.33%, and preferably about 0.39% to about 1.04%, by volume, of the entire therapeutic lotion. However, lotions with a pure AMH concentration as high as about 6.33% by volume are both safe and effective.
An especially preferred therapeutic lotion composition is identified herein as xe2x80x9cNumber 4 formulation.xe2x80x9d This formulation contains 60 ml (circa 2 fluid ounces) of 7.25% by volume aqueous sodium hypochlorite solution and 532 ml (circa 18 fluid ounces) of ST. IVE""S THERAPY LOTION(trademark) (whose ingredients have already been described).
The therapeutic lotion may be mixed with other ingredients, depending upon the ailment. For example, the therapeutic lotion may contain Vaseline and Preparation Hxe2x80x94especially in treating ailments involving inflammation and itching, such as hemorrhoids. Furthermore, fragrants may be added to mask the smell of the AMH.
The AMH penetrates into the subcutaneous tissue through the skin pores and lymph nodes. The AMH treats, and sometimes cures, a number of ailments, including microbial (e.g., viral, bacterial, fungal and parasitic) infection, hemorrhoids, arthritis, allergies, etc . . . The AMH does not adversely affect the user""s immune system or the healthy cells in the body. In fact, the AMH is believed to vitalize the user""s immune system and, thereby, promote the healing process.
In practice, the user rubs the composition onto or about the affected area of the body. For example, in the treatment of colds and allergies, the composition is applied about the eyes and nose of the user. Due to the presence of the skin lotion, the AMH (e.g., sodium hypochlorite) remains in a liquid state for more than 20 minutes which is sufficient time for it to penetrate the pores and lymph nodes of the user. When the composition eventually drys out, the user can easily wash it off the surface of the skin. In most cases, multiple applications are needed. However, the number and frequency of applications needed will vary depending upon the severity and type of ailment treated. Generally, however, the treatment is applied at least once a day.
Treatment with the therapeutic lotion may be used in conjunction with other treatments. This is especially true when the other treatment is a high concentration therapeutic bath of sodium hypohalite and water. Such a bath is described in detail in a concurrently filed and copending patent application listing the same inventors.
The following examples illustrate, but do not limit, the invention by detailing a preferred embodiment and the efficacy of the same in treating a variety of ailments: